New Port Richey, Florida 34652

  • Prostate Cancer

Purpose:

A clinical trial examining the safety and effectiveness of ABX-EGF when given to patients with prostate cancer with or without tumor in other parts of the body. Patients will be treated for a maximum of 48 doses (6 treatment courses; 8 doses per course) or until evidence of progressive disease.


Criteria:

Inclusion Criteria: - Male 18 years of age or older - Has tumor tissue available for diagnostics - Failed front line luteinizing hormone-releasing hormone analogue (LHRH) such as leuprolide or goserelin, or failed orchiectomy, as evidenced by disease progression. Patients must continue on a LHRH analogue (unless the patient had an orchiectomy) throughout the course of the study - ECOG score of 0 or 1 Exclusion Criteria: - Any prior chemotherapy for prostate cancer besides hormonal therapy (including no prior EGFr targeting agent) - Prior history of cancer other than prostate carcinoma within the past 5 years that has required treatment or been active (prior basal cell carcinoma is allowed) - Known to be HIV positive - Myocardial infarction within one year prior to entering the study


Study is Available At:


Original ID:

ABX-0310


NCT ID:

NCT00061126


Secondary ID:

ABX-EGF


Study Acronym:


Brief Title:

ABX-EGF (a Monoclonal Antibody) Given to Patients With Prostate Cancer With or Without Tumor in Other Parts of the Body


Official Title:

A Clinical Trial Evaluating the Safety and Efficacy of ABX-EGF in Patients With Hormone Resistant Prostate Cancer With or Without Metastasis


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

Male


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Abgenix


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Non-Randomized, Endpoint Classificati


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

50


Enrollment Type:


Study Dates

Start Date:April 2003
Verification Date:September 2004
Last Changed Date:June 23, 2005
First Received Date:May 21, 2003

Study Outcomes

There are no available Study Outcomes

Study Interventions

Intervention Type:Drug
Name:ABX-EGF

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Abgenix
Agency Class:Industry
Agency Type:Collaborator
Agency Name:Immunex Corporation

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: April 03, 2020

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